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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 45 Results
Analyte Hemoglobin Complexity waived Effective Date To 04/23/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
AimStrip Hb Hemoglobin (Hb) Testing System  
K122553   Hemoglobin Hematology 03/21/2014
Clarity HbCheck Hemoglobin Testing System  
K122553   Hemoglobin Hematology 02/18/2014
Alere HemoPoint H2 System  
K081719   Hemoglobin Hematology 12/12/2013
Alere HemoPoint H2 Hemoglobin System  
K081719   Hemoglobin Hematology 08/22/2013
Avie Total Hb Test System  {Professional Use} 
K121752   Hemoglobin Hematology 01/07/2013
Bayer A1C Now SelfCheck  
K090413   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
Bayer A1CNow + Professional Use  
K090413   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
Diaspect Hemoglobin Measuring System  
BK110036   Hemoglobin Hematology 04/05/2012
Alere HemoPoint H2 Hemoglobin Measurement System  
K081719   Hemoglobin Hematology 10/05/2011
Stanbio HemoPoint H2 DM Hemoglobin Measurement System  {with Data Management} 
K090093   Hemoglobin Hematology 06/12/2009

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